MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS; MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL

Model Number	35113
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint product was not returned for evaluation; however, the reporter provided photographic evidence.Analysis of the photo provided confirmed the reported complaint.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be low.Monitoring for trends will continue.The device history record for lot cm4190002 was reviewed, and confirmed that the product was manufactured according to specifications.All information reasonably known as of 12 dec 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and identified as (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sunmed holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported that a hole in the cuff was discovered during patient use.There was no delay in therapy, nor any harm or injury reported as a result of this event.

• Brand Name: AVANOS
• Common Device Name: MICROCUFF* PEDIATRIC ENDOTRACHEAL TUBE, ORAL/NASAL MAGILL
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 winward parkway; alpharetta GA 30004
• Manufacturer (Section G): COMMAND MEDICAL NICARAGUA SA; km 12.5 carretera norte; parque industrial las mercedes; edificia 16, managua ; NU
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 23793094
• Report Number: 3011270181-2025-20012
• Device Sequence Number: 17529572
• Product Code: BTR
• UDI-Device Identifier: 00609038351131
• UDI-Public: (01)00609038351131(17)290807(10)CM4190002(11)240708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35113
• Device Catalogue Number: 35113
• Device Lot Number: CM4190002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown